What is a Expedited Review?

An expedited review is a fast-tracked evaluation process used by regulatory agencies, such as the FDA, to assess applications for drugs, medical devices, or other products that address urgent medical needs or offer significant benefits over existing treatments. This process allows for quicker access to potentially life-saving therapies while still ensuring safety and efficacy standards are met. Expedited reviews can be granted based on factors like serious conditions, unmet medical needs, or promising preliminary data.